Z-1125-2019Class II

cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number...

Name: Z-1125-2019 cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number...
Creator: Roche Diagnostics Corporation
Published: 2018-12-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-12-14 / Terminated / root cause: design

FDA source

Roche Diagnostics Corporation began a recall of cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number... on 2018-12-14. FDA classified it as Class II and gives the reason as "COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1125-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-14
Posted: 2019-04-10
Terminated: 2020-09-04
Recalling firm: Roche Diagnostics GmbH
Product: cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis Tina-quant Albumin Gen.2 Immunoturbidimetric assay for the quantitative, in vitro determination of albumin in human urine, serum, plasma, and CSF on Roche/Hitachi cobas c systems
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
Root cause tag: design
FDA root cause: Device Design
Action: Roche Diagnostics issued on 12/14/18 "Urgent Medical Device Correction (UMDC) via UPS Ground (receipt required) Consignee Instructions: Manually add the EWCs listed in the Urgent Medical Device Correction (UMDC) on your COBAS INTEGRA 400 plus and cobas c 111 analyzers. If customers run the test combinations requiring needle assignment (See Table on page 3 of UMDC TP-00508), run those in batch mode until the updated TAS has been loaded on the COBAS INTEGRA 400 Plus analyzer. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions.
Quantity in commerce: 137 units
Distribution: US Nationwide distribution.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1125-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1124-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10
Z-1125-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10

Product code JJE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)